Medical devices and manufacturing.
From your first QMS to MDSAP certification, ARTG inclusion and FDA 510(k), I help start-ups, multinationals and university spin-outs get compliant without building a bureaucracy. BSI-trained ISO 13485 Lead Auditor, with 15+ years in medical devices, pharmaceuticals and diagnostics.
Services
ISO 13485 gap analysis
A clause-by-clause review of where you are against the standard, with a ranked list of what to fix first.
QMS build and implementation
Procedures, records and training written for your size and device class, then rolled out with your team.
Pre-certification and internal audits
A realistic audit before the certification body arrives, with clear findings and no box-ticking.
Supplier audits and management
Qualify and monitor suppliers with controls that match the risk.
Regulatory pathways
TGA ARTG inclusion and FDA 510(k) planning, so you know the evidence you need before you spend on testing.
Recalls and adverse events
Field safety corrective actions, health hazard evaluations and adverse event reporting, handled calmly.
Australian sponsor set-up
The bridge between an offshore manufacturer or parent company and a compliant Australian sales operation.
Standards I work to
ISO 13485:2016 · ISO 9001:2015 · ISO 14971:2019 · ISO 10993 · MDSAP · EU MDR · 21 CFR Part 820 · GMP · TGA Essential Principles
Choosing a certification body
I took 360MedCare to MDSAP certification and have hosted BSI audits covering ISO 13485, MDSAP and EU MDR. I know the strengths and pitfalls of DNV, TÜV, BSI and TQCSI, and I'll help you choose once and choose well.
Integration and growth
I've consolidated four businesses into one site and harmonised their quality systems through an acquisition. If you're acquiring, merging or moving, I'll help you keep certification and supply intact through the change.
Questions I get asked
Do we need a QMS?
If you design, make or supply medical devices, almost certainly. ISO 13485 is the usual route, and the right size depends on your device class and markets.
Which certification body should we use?
It depends on your scope, markets and timeline. I'll compare the options with you before you sign anything.
How do we get regulatory approval for our device?
In Australia, devices are included in the ARTG through a sponsor. In the US, most moderate-risk devices need a 510(k). I map the pathway and the evidence first, so testing money is spent once.
Which standards should we validate our processes against?
That depends on the process and the product. I'll show you which standards apply and which only look like they do.
Book 20 minutes.
Tell me where you are and where you need to get to. If I'm not the right fit, I'll tell you who is.
Dave Tiernan · Noosa Heads, QLD
0420 548 781 · info@bespokeqs.com · LinkedIn